Clinical Trials /

A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

NCT04210219

Description:

The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D[s]) in B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part 1 and to evaluate the safety of JNJ-64264681 at the RP2D(s) in Part 2.

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia
  • Official Title: A Phase 1, Open-Label Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-64264681 in Participants With Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: CR108706
  • SECONDARY ID: 2019-003194-25
  • SECONDARY ID: 64264681LYM1001
  • NCT ID: NCT04210219

Conditions

  • Lymphoma, Non-Hodgkin
  • Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

DrugSynonymsArms
JNJ-64264681JNJ-64264681: Dose Escalation and Expansion

Purpose

The purpose of the study is to determine the recommended Phase 2 dose(s) (RP2D[s]) in B cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) in Part 1 and to evaluate the safety of JNJ-64264681 at the RP2D(s) in Part 2.

Trial Arms

NameTypeDescriptionInterventions
JNJ-64264681: Dose Escalation and ExpansionExperimentalParticipants will receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET), based on the available safety, pharmacokinetics, and pharmacodynamics data in dose escalation treatment group (Part 1); and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2).
  • JNJ-64264681

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have Eastern Cooperative Oncology Group (ECOG) performance status
             grade of 0 or 1

          -  Participants must have cardiac parameters within the following range: corrected QT
             interval (QTcF) less than or equal to <= 480 milliseconds based on the average of
             triplicate assessments performed as close as possible in succession (the full set of
             triplicates should be completed in less than 10 minutes)

          -  Women of childbearing potential must have a negative highly sensitive serum pregnancy
             test (example: beta human chorionic gonadotropin [beta-hCG]) at screening, and a
             negative serum or urine pregnancy test prior to the first dose of study drug

          -  Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted
             reproduction during the study and for a period of at least 30 days after the last
             study drug administration

          -  Participants must be willing and able to adhere to the lifestyle restrictions
             specified in this protocol

        Exclusion Criteria:

          -  Participant has known active central nervous system (CNS) involvement

          -  Participant has received prior solid organ transplantation

          -  Participant has known allergies, hypersensitivity, or intolerance to JNJ-64264681 or
             its excipients

          -  Participant has been treated with an investigational drug (including investigational
             vaccines) within five half-lives or 2 weeks (whichever is longer) before the planned
             first dose of study drug

          -  Participant is experiencing toxicities from previous anticancer therapies that have
             not resolved to baseline levels, or to Grade 1 or less (except for alopecia and
             peripheral neuropathy)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Time Frame:Up to 21 days
Safety Issue:
Description:The DLTs are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher (as specified in protocol).

Secondary Outcome Measures

Measure:Plasma Concentration of JNJ-64264681
Time Frame:Up to 2 years
Safety Issue:
Description:Plasma concentration of JNJ-64264681 will be evaluated.
Measure:Percentage Occupancy of the Target
Time Frame:Up to 2 years
Safety Issue:
Description:The pharmacodynamics of JNJ-64264681 will be assessed by determining the percentage of target occupancy. Blood samples will be obtained for pharmacodynamic assessments (target occupancy).
Measure:Overall Response Rate (ORR)
Time Frame:Up to 2 years
Safety Issue:
Description:ORR is defined as the percentage of participants who achieve a complete response (CR) + partial response (PR) or better according to the Revised Response Criteria for Malignant Lymphoma and the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Response Criteria and International Workshop for Waldenstrom Macroglobulinemia (IWWM) Response Criteria.
Measure:Time to Response (TTR)
Time Frame:Up to 2 years
Safety Issue:
Description:TTR is defined for participants who achieved PR or CR as the time from the first dose of study drug to first response of PR or CR according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria.
Measure:Duration of Response (DOR)
Time Frame:Up to 2 years
Safety Issue:
Description:DOR is defined for participants who achieved PR or CR as the time between the date of initial documentation of PR or CR to the date of either the first documented evidence of disease progression or death according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria.
Measure:Complete Response (CR) Rate
Time Frame:Up to 2 years
Safety Issue:
Description:CR rate is defined as the percentage of participants who achieve a best response of CR according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria.
Measure:Progression-free Survival (PFS)
Time Frame:Up to 2 years
Safety Issue:
Description:PFS is defined as the time from the date of the first dose of the study drug to the date of either the first documented disease progression (according to the Revised Response Criteria for Malignant Lymphoma and iwCLL Response Criteria and IWWM Response Criteria), or death due to any cause.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Janssen Research & Development, LLC

Last Updated

September 11, 2020